Abbott

Sr. IT Compliance Analyst - CAPA

Abbott • $78K — $156K *
Waukegan, IL 60085In-Person
Healthcare
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree or equivalent certification or experience required.
  • 5+ years in IT project delivery and application support, with 2-4 years in CAPA and regulated quality systems.
  • CAPA Certified Event Owner certification preferred or must be willing to obtain.
  • Strong analytical skills and sound judgment with consultative abilities.
  • Proven relationship-building and effective communication skills.

Responsibilities

  • Lead IT compliance for CAPA event evaluations and corrective actions.
  • Assemble and coordinate cross-functional teams for CAPA resolutions.
  • Provide leadership and guidance on CAPA processes and compliance procedures.
  • Manage projects to ensure timely completion of CAPA events.
  • Monitor implementation plans and escalate issues as needed.
  • Prepare and approve documentation in accordance with policy for CAPA activities.
  • Support development of AI processes to enhance compliance efforts.

Benefits

  • Health and wellness benefits available for you and your family.
  • Opportunities for career advancement and diverse roles within Abbott.
  • Access to a robust support system to help balance work and life.
Full Job Description
JOB DESCRIPTION:

The Opportunity

Our location in Lake County, IL currently has an opportunity for Sr IT Compliance Analyst - CAPA. Establishes and maintains productive relationships with all levels in the BTS and Divisional IT organizations and business functions. Acts as a liaison and IT Compliance expert to assure successful investigations and corrective actions. Serves as a source of information on the IT Compliance needs and regulatory environment.

What You'll Work On
  • Leads the IT Compliance activities for specific CAPA (Corrective and Preventive Action) event evaluations, investigations, and resolution planning.
  • Assembles CAPA CFT (cross-functional team) team with all needed parties/expertise to effectively and efficiently address assigned CAPA events.
  • Provides understanding and leadership of CAPA processes, SLC, validation and compliance processes/procedures to CAPA CFT (and other stakeholders as needed).
  • Exercises Project management skills to drive for completion of CAPA events (assignment of action ownership, details, milestone dates)
  • Ensures CAPA events are investigated and remediated according to schedule.
  • Applies IT project delivery, application support and compliance knowledge and experience to investigations.
  • Monitors implementation plan and effectiveness check due dates and work with BTS IT owners to ensure implementations are completed on time.
  • Escalates status, implementation, and effectiveness issues to CAPA management as needed.
  • Prepares and approves documentation per policy and procedure to support CAPA activities.
  • Accountable for capturing, reporting, and evolving the CAPA metric data for BTS. Prepares management review metrics for upper management communications and provides input as needed for GMR metrics
  • Apply AI technologies and agent-based solutions to improve quality processes, support investigations and compliance activities, and expand AI expertise through ongoing learning and best practice adoption.
  • Core Job Responsibilities
  • Develops the CAPA strategy and approach for CAPA events.
  • Assembles and leads CFT (virtual or onsite) to develop, review and approve CAPA documentation (evaluation, investigation, containment, resolution, implementation, and effectiveness checks) in support of IT quality activities.
  • Applies critical thinking and reasoning skills to incorporate CFT input into a well-organized and complete CAPA event record.
  • Implements technical writing and clear and concise conclusions in the documentation of CAPA events.
  • Performs work using BTS Quality System methodologies, processes, and tools to ensure IT Compliance.
  • Resolve issues that may delay the CAPAs or otherwise subject the company to financial or regulatory risk.
  • Support the development and oversight of AI agents and AI-enabled processes, ensuring responsible AI usage, compliance with company policies, and continuous advancement of AI knowledge and capabilities across the organization.
  • Works with minimal management direction. Drives completion of CAPAs by organizing and monitoring the efforts of CAPA SME teams.
  • Independently conceives and develops approaches to the solution of CAPA events which require application of IT compliance principles.
  • Errors or failure to achieve expected results may result in quality issues and/or the expenditure of more resources or impact IT compliance.

Education & Required Qualifications:
  • Bachelor's Degree or equivalent certification or experience. No advanced degree required

Required Experience:
  • Overall 5+ years of experience in IT project delivery, IT application support, SLC methodologies with about 2-4 years in CAPA and regulated quality systems environment.
  • The individual should either be a CAPA Certified Event Owner or be willing to obtain certification.
  • Strong analytical thinking, sound judgment, consultative skills, and the ability to effectively partner with both IT management and technical teams.
  • Proven ability to build strong stakeholder relationships, drive results, and communicate effectively through both verbal and written channels.

Preferred Experience:
  • Familiarity with AI technologies and agent-based solutions to improve quality processes.
  • AQR certifications.
  • Life sciences industry background

Misc: This is an onsite role at Abbott location in IL This is not a remote role/opportunity.

Apply Now
  • Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
  • Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
  • Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.


The base pay for this position is
$78,000.00 - $156,000.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Information Risk & Quality Assurance

DIVISION:
BTS Business Technology Services

LOCATION:
United States > Waukegan : J46

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 5 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Abbott

More Healthcare Jobs

Find similar Sr. IT Compliance Analyst - CAPA jobs:

NationwideWaukegan, IL